NAPSRx News: Shire submits NDA for new eye treatment -Lifitegrast

WASHINGTON - March 3, 2015 - PRLog -- Shire has submitted a New Drug Application (NDA) with the U. S. Food and Drug Administration for a novel small-molecule integrin inhibitor called Lifitegrast to treat dry eye disease symptoms in adults.  A multifactorial disease, dry eye can result in significant discomfort, cause visual disturbance and tear instability with potential damage to the ocular surface.

Sufficient evidence to support the NDA submission stems from four clinical trials involving 1,800 patients.  The clinical trials encompassed one Phase 2 Study, two Phase 3 efficacy and safety studies, an one long-term Phase 2 safety study. “Lifitegrast has potential to be the first treatment indicated to address both the signs and symptoms of dry eye disease, a chronic inflammatory condition which affects millions of people,” said Philip J. Vickers, Ph.D., Head of Research and Development, Shire. “Our FDA submission is an important milestone that underscores Shire’s commitment to developing innovative specialty medicines in areas of high unmet medical need.”

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